The process for registering a Class I medical device with Roszdravnadzor (RZN), Russia’s health regulatory authority, involves several key steps. Class I devices are considered low-risk, so the registration process is relatively straightforward. Below is an outline of the steps involved:

Steps to Register a Class I Medical Device with Roszdravnadzor (RZN)

1. Prepare Documentation

You must collect and prepare the following documents:

• Application form for registration (available on the RZN portal).
• Certificate of Free Sale (CFS) from the country of origin, indicating the device is legally marketed there.
• Product Description: This includes detailed information about the device, such as its intended use, design, technical specifications, and how it functions.
• Instructions for Use (IFU): A user manual in Russian, outlining how the device should be used.
• Manufacturing Information: Details of the manufacturer, including a valid quality management system (e.g., ISO 13485).
• Labeling Information: Packaging and labels must be in Russian.
• Risk Management File: An assessment of the potential risks associated with the device, though this might be simpler for Class I devices.
• Clinical or Performance Data: Not usually required for Class I devices unless specified.

2. Submit the Application

Once you have all the necessary documents, submit your application to Roszdravnadzor either:

• Online: Through the official RZN portal (e.g., using their electronic submission system).
• In-person: By submitting the documents to Roszdravnadzor’s office.

All documents in foreign languages (e.g., CFS, manufacturing certificates) must be translated into Russian.

3. Roszdravnadzor Review

• Document Review: Roszdravnadzor will review the submitted documents to ensure they meet Russian regulations for medical devices.
• Compliance Check: They will verify that the device complies with the technical regulations, safety standards, and quality requirements set by Russian authorities.
• Additional Information: If necessary, Roszdravnadzor may request additional information or clarifications during the review process.

4. Issuance of Registration Certificate

• If everything is in order, Roszdravnadzor will issue the registration certificate, confirming that the medical device can be legally sold and marketed in Russia.
• The registration certificate is typically valid for 5 years. After this period, you must apply for renewal.

5. Post-Registration Obligations

• After registration, ensure the device continues to comply with Russian safety and performance standards.
• If any significant changes occur in the device design, labeling, or manufacturing process, you may need to notify Roszdravnadzor or re-register the device.
• Keep track of any adverse events or issues that could affect device safety and inform Roszdravnadzor if necessary.

Timeline

• The registration process for Class I devices typically takes 3 to 6 months, depending on the completeness of the documentation and any additional requests from Roszdravnadzor.

Cost

• Registration fees are typically lower for Class I devices compared to higher-risk devices. However, it’s important to confirm the exact fees on the Roszdravnadzor website or through a local regulatory expert.

Key Considerations

• Simpler Requirements: Class I medical devices face less stringent requirements compared to higher-risk devices, but compliance with Russian regulations is still crucial.
• Language Requirements: All labeling, instructions for use, and critical documents must be provided in Russian.
• Regulatory Expertise: Navigating the Russian regulatory landscape can be complex, so it may be helpful to consult with a local expert to ensure full compliance.

By following these steps and ensuring all documentation is accurate and complete, you can successfully register a Class I medical device with Roszdravnadzor in Russia.

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